Trial Outcomes & Findings for Investigation of Non-CE Marked Intermittent Catheters. (NCT NCT04543136)

NCT ID: NCT04543136

Last Updated: 2023-07-13

Results Overview

The residual urine at 1st flow-stop during nurse catheterization (i.e., catheterization performed by the nurse) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying/urination. This was assessed using a pressure sensor with time-logged weighing, meaning that a flow-stop was registered measuring the hydrostatic pressure at the outlet of an intermittent urinary catheter. Simultaneously, the collected urine was weighed and converted to volume, and the residual volume at first flow stop was calculated as the difference between the total urine volume collected and the volume collected at the first flow-stop.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 16 participants
• Primary outcome timeframe: Immediately after the procedure/catheterization, up to 5 min.
• Results posted on: 2023-07-13

Participant Flow

Between June 2020 and January 2021,16 users were recruited for the study from one site (Denmark) and encompassed the safety population.

The 16 recruited participant were randomized into the three treatment arms, using a randomization sequence of six. No participants were excluded, but two were discontinued at own wish after the baseline visit. Three participants had an adverse event; all were classified as mild, non-serious, two as 'Possibly related' and one as 'Unlikely related' (for details; see Adverse Events section). Thus, 14 participants constituted the intention to treat (ITT) population.

Participant milestones

Measure	Comparator, Then Variant 2, Then Variant 1 On three separate visits and in the listed random order, the participants underwent three interventions: First intervention: Day of catheterization with Comparator. Washout: 4-14 days. Second intervention: Day of catheterization with Variant 2. Washout: 4-14 days. Third intervention: Day of catheterization with Variant 1.	Variant 2, Then Variant 1, Then Comparator On three separate visits and in the listed random order, the participants underwent three interventions: First intervention: Day of catheterization with Variant 2. Washout: 4-14 days. Second intervention: Day of catheterization with Variant 1. Washout: 4-14 days. Third intervention: Day of catheterization with Comparator.	Comparator, Then Variant 1, Then Variant 2 On three separate visits and in the listed random order, the participants underwent three interventions: First intervention: Day of catheterization with Comparator. Washout: 4-14 days. Second intervention: Day of catheterization with Variant 1. Washout: 4-14 days. Third intervention: Day of catheterization with Variant 2.	Variant 1, Then Comparator, Then Variant 2 On three separate visits and in the listed random order, the participants underwent three interventions: First intervention: Day of catheterization with Variant 1. Washout: 4-14 days. Second intervention: Day of catheterization with Comparator. Washout: 4-14 days. Third intervention: Day of catheterization with Variant 2.	Variant 1, Then Variant 2, Then Comparator On three separate visits and in the listed random order, the participants underwent three interventions: First intervention: Day of catheterization with Variant 1. Washout: 4-14 days. Second intervention: Day of catheterization with Variant 2. Washout: 4-14 days. Third intervention: Day of catheterization with Comparator.	Variant 2, Then Comparator, Then Variant 1 On three separate visits and in the listed random order, the participants underwent three interventions: First intervention: Day of catheterization with Variant 2. Washout: 4-14 days. Second intervention: Day of catheterization with Comparator. Washout: 4-14 days. Third intervention: Day of catheterization with Variant 1.
Overall Study STARTED	3	3	2	3	2	3
Overall Study COMPLETED	3	2	2	2	2	3
Overall Study NOT COMPLETED	0	1	0	1	0	0

Reasons for withdrawal

Measure	Comparator, Then Variant 2, Then Variant 1 On three separate visits and in the listed random order, the participants underwent three interventions: First intervention: Day of catheterization with Comparator. Washout: 4-14 days. Second intervention: Day of catheterization with Variant 2. Washout: 4-14 days. Third intervention: Day of catheterization with Variant 1.	Variant 2, Then Variant 1, Then Comparator On three separate visits and in the listed random order, the participants underwent three interventions: First intervention: Day of catheterization with Variant 2. Washout: 4-14 days. Second intervention: Day of catheterization with Variant 1. Washout: 4-14 days. Third intervention: Day of catheterization with Comparator.	Comparator, Then Variant 1, Then Variant 2 On three separate visits and in the listed random order, the participants underwent three interventions: First intervention: Day of catheterization with Comparator. Washout: 4-14 days. Second intervention: Day of catheterization with Variant 1. Washout: 4-14 days. Third intervention: Day of catheterization with Variant 2.	Variant 1, Then Comparator, Then Variant 2 On three separate visits and in the listed random order, the participants underwent three interventions: First intervention: Day of catheterization with Variant 1. Washout: 4-14 days. Second intervention: Day of catheterization with Comparator. Washout: 4-14 days. Third intervention: Day of catheterization with Variant 2.	Variant 1, Then Variant 2, Then Comparator On three separate visits and in the listed random order, the participants underwent three interventions: First intervention: Day of catheterization with Variant 1. Washout: 4-14 days. Second intervention: Day of catheterization with Variant 2. Washout: 4-14 days. Third intervention: Day of catheterization with Comparator.	Variant 2, Then Comparator, Then Variant 1 On three separate visits and in the listed random order, the participants underwent three interventions: First intervention: Day of catheterization with Variant 2. Washout: 4-14 days. Second intervention: Day of catheterization with Comparator. Washout: 4-14 days. Third intervention: Day of catheterization with Variant 1.
Overall Study Withdrawal by Subject	0	1	0	1	0	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Total ITT Population n=14 Participants Each treatment arm consisted of three test visits with 4-14 days between each crossover. On each visit, the participants underwent intermittent catheterization through the urethra, draining the bladder, and tested a different intermittent catheter: The comparator catheter (SpeediCath® Standard female), the new Variant 1 catheter, or the new Variant 2 catheter. For each visit and catheter tested, the participants underwent two catheterizations; the first catheterization was performed by a trained nurse and was followed by later same-day self-catheterization (i.e. performed by the participant).
Age, Categorical <=18 years	0 Participants n=14 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=14 Participants
Age, Categorical >=65 years	7 Participants n=14 Participants
Age, Continuous	55 years n=14 Participants
Sex: Female, Male Female	0 Participants n=14 Participants
Sex: Female, Male Male	14 Participants n=14 Participants
Region of Enrollment Denmark	14 Participants n=14 Participants
Number of participants with neurogenic bladder dysfunction	9 Participants n=14 Participants
Number of participants with non-neurogenic bladder dysfunction	5 Participants n=14 Participants
Number of participants in sitting catheterization position	8 Participants n=14 Participants
Number of participants in standing catheterization position	6 Participants n=14 Participants

PRIMARY outcome

Timeframe: Immediately after the procedure/catheterization, up to 5 min.

Population: The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints.

The residual urine at 1st flow-stop during nurse catheterization (i.e., catheterization performed by the nurse) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying/urination. This was assessed using a pressure sensor with time-logged weighing, meaning that a flow-stop was registered measuring the hydrostatic pressure at the outlet of an intermittent urinary catheter. Simultaneously, the collected urine was weighed and converted to volume, and the residual volume at first flow stop was calculated as the difference between the total urine volume collected and the volume collected at the first flow-stop.

Outcome measures

Measure	Intermittent Catheter; SpeediCath® Standard Male n=14 Participants Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.	New Intermittent Catheter Variant 1 for Males n=14 Participants Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.	New Intermittent Catheter Variant 2 for Males n=14 Participants Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.
Residual Urine at 1st Flow-stop During Nurse Catheterization	59.4 mL Standard Deviation 99.6	13.1 mL Standard Deviation 26.7	0.4 mL Standard Deviation 1.66

PRIMARY outcome

Timeframe: Immediately after the procedure/catheterization, up to 5 min.

Population: The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints.

The residual urine at 1st flow-stop during nurse catheterization (i.e., catheterization performed by the participant) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying/urination. This was assessed using a pressure sensor with time-logged weighing, meaning that a flow-stop was registered measuring the hydrostatic pressure at the outlet of an intermittent urinary catheter. Simultaneously, the collected urine was weighed and converted to volume, and the residual volume at first flow stop was calculated as the difference between the total urine volume collected and the volume collected at the first flow-stop.

Outcome measures

Measure	Intermittent Catheter; SpeediCath® Standard Male n=14 Participants Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.	New Intermittent Catheter Variant 1 for Males n=14 Participants Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.	New Intermittent Catheter Variant 2 for Males n=14 Participants Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.
Residual Urine at 1st Flow-stop During Self-catheterization	61.8 mL Standard Deviation 117.7	5.7 mL Standard Deviation 19.7	0.0 mL Standard Deviation 0.0

SECONDARY outcome

Timeframe: Immediately after the procedure/catheterization, up to 15 min.

Population: The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints.

The volume of residual urine (urine left in the bladder) post catheterization (performed by the nurse) measured in triplicates using an ultrasound scanner.

Outcome measures

Measure	Intermittent Catheter; SpeediCath® Standard Male n=14 Participants Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.	New Intermittent Catheter Variant 1 for Males n=14 Participants Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.	New Intermittent Catheter Variant 2 for Males n=14 Participants Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.
Post-void Residual Urine After Nurse Catheterization	24.6 mL Standard Deviation 39.8	36.4 mL Standard Deviation 56.5	12.7 mL Standard Deviation 26.6

SECONDARY outcome

Timeframe: Immediately after the procedure/catheterization, up to 15 min.

Population: The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints.

The volume of residual urine (urine left in the bladder) post catheterization (performed by the participant) measured in triplicates using an ultrasound scanner.

Outcome measures

Measure	Intermittent Catheter; SpeediCath® Standard Male n=14 Participants Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.	New Intermittent Catheter Variant 1 for Males n=14 Participants Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.	New Intermittent Catheter Variant 2 for Males n=14 Participants Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.
Post-void Residual Urine After Self-catheterization	33.9 mL Standard Deviation 43.9	29.0 mL Standard Deviation 53.16	27.0 mL Standard Deviation 41.8

SECONDARY outcome

Timeframe: Immediately after the procedure/catheterization, up to 5 min.

Population: The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints.

Discomfort measured at catheter insertion (performed by nurse), using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.

Outcome measures

Measure	Intermittent Catheter; SpeediCath® Standard Male n=14 Participants Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.	New Intermittent Catheter Variant 1 for Males n=14 Participants Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.	New Intermittent Catheter Variant 2 for Males n=14 Participants Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.
Insertion Discomfort During Nurse Catheterization	0.59 cm Standard Deviation 1.01	0.66 cm Standard Deviation 1.16	1.20 cm Standard Deviation 1.59

SECONDARY outcome

Timeframe: Immediately after the procedure/catheterization, up to 5 min.

Population: The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints.

Discomfort measured during catheter urination/emptying (performed by nurse), using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.

Outcome measures

Measure	Intermittent Catheter; SpeediCath® Standard Male n=14 Participants Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.	New Intermittent Catheter Variant 1 for Males n=14 Participants Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.	New Intermittent Catheter Variant 2 for Males n=14 Participants Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.
Urination Discomfort During Nurse Catheterization	0.44 cm Standard Deviation 1.22	0.22 cm Standard Deviation 0.33	0.17 cm Standard Deviation 0.24

SECONDARY outcome

Timeframe: Immediately after the procedure/catheterization, up to 5 min.

Population: The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints.

Discomfort measured during catheter withdrawal (performed by nurse), using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.

Outcome measures

Measure	Intermittent Catheter; SpeediCath® Standard Male n=14 Participants Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.	New Intermittent Catheter Variant 1 for Males n=14 Participants Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.	New Intermittent Catheter Variant 2 for Males n=14 Participants Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.
Withdrawal Discomfort During Nurse Catheterization	0.41 cm Standard Deviation 0.89	0.32 cm Standard Deviation 0.44	0.59 cm Standard Deviation 1.16

SECONDARY outcome

Timeframe: Immediately after the procedure/catheterization, up to 5 min.

Population: The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints.

Discomfort measured for the entire catheterization procedure (performed by nurse), using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.

Outcome measures

Measure	Intermittent Catheter; SpeediCath® Standard Male n=14 Participants Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.	New Intermittent Catheter Variant 1 for Males n=14 Participants Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.	New Intermittent Catheter Variant 2 for Males n=14 Participants Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.
Overall Discomfort During Nurse Catheterization	0.66 cm Standard Deviation 1.68	0.79 cm Standard Deviation 1.78	0.72 cm Standard Deviation 1.09

SECONDARY outcome

Timeframe: Immediately after the procedure/catheterization, up to 5 min.

Population: The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints.

Discomfort measured at catheter insertion (performed by participant), using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.

Outcome measures

Measure	Intermittent Catheter; SpeediCath® Standard Male n=14 Participants Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.	New Intermittent Catheter Variant 1 for Males n=14 Participants Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.	New Intermittent Catheter Variant 2 for Males n=14 Participants Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.
Insertion Discomfort During Self-catheterization	0.24 cm Standard Deviation 0.33	0.53 cm Standard Deviation 0.73	0.73 cm Standard Deviation 0.93

SECONDARY outcome

Timeframe: Immediately after the procedure/catheterization, up to 5 min.

Population: The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints.

Discomfort measured during catheter urination/emptying (performed by participant), using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.

Outcome measures

Measure	Intermittent Catheter; SpeediCath® Standard Male n=14 Participants Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.	New Intermittent Catheter Variant 1 for Males n=14 Participants Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.	New Intermittent Catheter Variant 2 for Males n=14 Participants Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.
Urination Discomfort During Self-catheterization	0.17 cm Standard Deviation 0.26	0.18 cm Standard Deviation 0.28	0.34 cm Standard Deviation 0.59

SECONDARY outcome

Timeframe: Immediately after the procedure/catheterization, up to 5 min.

Population: The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints.

Discomfort measured during catheter withdrawal (performed by participant), using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.

Outcome measures

Measure	Intermittent Catheter; SpeediCath® Standard Male n=14 Participants Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.	New Intermittent Catheter Variant 1 for Males n=14 Participants Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.	New Intermittent Catheter Variant 2 for Males n=14 Participants Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.
Withdrawal Discomfort During Self-catheterization	0.15 cm Standard Deviation 0.24	0.21 cm Standard Deviation 0.31	0.55 cm Standard Deviation 1.14

SECONDARY outcome

Timeframe: Immediately after the procedure/catheterization, up to 5 min.

Population: The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints.

Discomfort measured for the entire catheterization procedure (performed by participant), using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.

Outcome measures

Measure	Intermittent Catheter; SpeediCath® Standard Male n=14 Participants Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.	New Intermittent Catheter Variant 1 for Males n=14 Participants Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.	New Intermittent Catheter Variant 2 for Males n=14 Participants Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.
Overall Discomfort During Self-catheterization	0.16 cm Standard Deviation 0.24	0.38 cm Standard Deviation 0.49	0.72 cm Standard Deviation 1.25

Adverse Events

Intermittent Catheter; SpeediCath® Standard Male

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

New Intermittent Catheter Variant 1 for Males

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

New Intermittent Catheter Variant 2 for Males

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intermittent Catheter; SpeediCath® Standard Male n=16 participants at risk Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.	New Intermittent Catheter Variant 1 for Males n=16 participants at risk Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.	New Intermittent Catheter Variant 2 for Males n=16 participants at risk Participants underwent intermittent catheterization through the urethra, draining the bladder. Two catheterizations were performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by trained nurses followed by later same-day self-catheterization by the participants.
Renal and urinary disorders Unlikely related	6.2% 1/16 • Number of events 1 • Each participant was enrolled for 3 x 4-14 days for the entire investigation, thus a maximum of 42 days. The relationship to the investigational or comparator products was collected. The safety population constituted the subjects who had given informed consent and were thus 16 participants. An adverse event was reported as either: "Not related", "Unlikely related", "Possibly related", "Probably related", or "Definitely related", to the comparator to the Variant 1 or Variant 2 products.	0.00% 0/16 • Each participant was enrolled for 3 x 4-14 days for the entire investigation, thus a maximum of 42 days. The relationship to the investigational or comparator products was collected. The safety population constituted the subjects who had given informed consent and were thus 16 participants. An adverse event was reported as either: "Not related", "Unlikely related", "Possibly related", "Probably related", or "Definitely related", to the comparator to the Variant 1 or Variant 2 products.	0.00% 0/16 • Each participant was enrolled for 3 x 4-14 days for the entire investigation, thus a maximum of 42 days. The relationship to the investigational or comparator products was collected. The safety population constituted the subjects who had given informed consent and were thus 16 participants. An adverse event was reported as either: "Not related", "Unlikely related", "Possibly related", "Probably related", or "Definitely related", to the comparator to the Variant 1 or Variant 2 products.
Renal and urinary disorders Possibly related	0.00% 0/16 • Each participant was enrolled for 3 x 4-14 days for the entire investigation, thus a maximum of 42 days. The relationship to the investigational or comparator products was collected. The safety population constituted the subjects who had given informed consent and were thus 16 participants. An adverse event was reported as either: "Not related", "Unlikely related", "Possibly related", "Probably related", or "Definitely related", to the comparator to the Variant 1 or Variant 2 products.	0.00% 0/16 • Each participant was enrolled for 3 x 4-14 days for the entire investigation, thus a maximum of 42 days. The relationship to the investigational or comparator products was collected. The safety population constituted the subjects who had given informed consent and were thus 16 participants. An adverse event was reported as either: "Not related", "Unlikely related", "Possibly related", "Probably related", or "Definitely related", to the comparator to the Variant 1 or Variant 2 products.	6.2% 1/16 • Number of events 1 • Each participant was enrolled for 3 x 4-14 days for the entire investigation, thus a maximum of 42 days. The relationship to the investigational or comparator products was collected. The safety population constituted the subjects who had given informed consent and were thus 16 participants. An adverse event was reported as either: "Not related", "Unlikely related", "Possibly related", "Probably related", or "Definitely related", to the comparator to the Variant 1 or Variant 2 products.

Additional Information

Vice President, Medical Affairs

Coloplast A/S

Phone: +4549111111

Email: clinical-studies@coloplast.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60